Glaucoma is a leading cause of blindness worldwide and is commonly treated with microinvasive glaucoma surgery (MIGS).
Nathan Radcliffe, MD, sits down in this episode of Interventional Mindset to provide and discuss updates regarding the ongoing changes around Medicare coverage of MIGS.
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Development of MIGS technology
MIGS technology has greatly advanced in recent decades. The development of iStent by Glaukos, the first implantable trabecular micro-bypass stent, paved the way for many of the current MIGS procedures. Implantable stents require FDA approval, which may only be obtained through a rigorous process of numerous trials to determine their effectiveness in treating glaucoma and have been administered to patients since.
Switching gears, the intracanalicular scaffold from Hydrus Microstent followed soon thereafter with a favorable safety profile and enhanced patient outcomes similar to that of the iStent. As micro-bypass stent usage increased, its Current Procedural Terminology (CPT) code was classified as a category 1 CPT code bundled with cataract surgery. Compensation for stents was re-evaluated and significantly decreased.
Ab-interno procedures, such as goniotomy and canaloplasty, often performed at the time of cataract surgery, also became increasingly popular. In fact, some surgeons were more comfortable performing these procedures compared to stent implantation. Surgeons could select the instrumentation to perform the procedure as long as the decision-making aligned with the intraocular pressure (IOP) reduction goal set forth for the surgery—whether it be removing the trabecular meshwork in goniotomy or inflating and expanding the canal in canaloplasty.
Changes to MIGS reimbursement
The first salvo of changes to MIGS reimbursement began in the fall of 2023 when several Medicare administrative contractors (MAC) released drafts of local coverage determinations (LCD) that targeted certain MIGS procedures. MACs, which cover different regions of the US, are organizations that administer Medicare insurance coverage.
In my professional opinion, these drafts appear to have been written without sufficient research of MIGS and relevant terminology, riddled with misspelled names and misclassifications. They declared that certain MIGS—including goniotomy, canaloplasty, and cyclophotocoagulation—did not have enough evidence to be considered for reimbursement.
These declarations were met with a strong uproar from the medical community, and many industry professionals appeared at the hearings of MAC regions targeting MIGS to present evidence-based explanations detailing the critical need for procedures, such as goniotomy and canaloplasty, to manage glaucoma cases that warranted further intervention beyond drop therapy. One study demonstrated that cataract surgery with goniotomy using the Kahook Dual Blade (KDB) was equally effective as cataract surgery with stent placement.1 From Dr. Radcliffe’s point of view, “multicenter, prospective studies such as this should be considered by Medicare and used to decide reimbursement.”
Since the widespread use of micro-bypass stents, angle procedures—like goniotomy and canaloplasty—have also become very popular. It is considered standard practice for many ECPs to implement goniotomy or canaloplasty during cataract surgery, especially when patients are looking to take fewer medications. In Dr. Radcliffe’s experience, every patient would like to reduce medication usage.
The American Academy of Ophthalmology (AAO), American Glaucoma Society (AGS), and Association of Cataract and Refractive Surgeons (ASCRS) released a joint statement with recommended revisions to these LCDs. These suggestions were virtually ignored by the MACs in their next draft, who decided to continue with the restriction of MIGS procedures.
Goniotomy was considered to be suitable only for patients with uncontrollable IOP on multiple drops, while canaloplasty was deemed experimental. Cyclophotocoagulation was concluded to be only appropriate for patients who have already had multiple glaucoma procedures and did not have useful vision. Dr. Radcliffe emphasizes the difficulty of managing glaucoma in such a restricted environment.
Additionally, in the final LCD, the MACs introduced new criteria for glaucoma procedures, outlining that they are only useful when demonstrating a 2-year 20% reduction in IOP. The MACs did not include this information in previous drafts as is protocol, prompting the societies to reach out to Medicare with requests that the administrators be prohibited from implementing these new policies.
At the time of this recording, professional medical societies are in communication with Medicare regarding these LCDs. The LCDs are tentatively set to be put into practice in January 2024, though this date may change.
Steps moving forward
Dr. Radcliffe recommends that patients remain up-to-date with news from medical societies to remain knowledgeable about how these legal proceedings may impact their glaucoma care. For surgeons and patients with scheduled upcoming procedures, it is critical to confirm they are still covered beforehand. Further, surgeons (and patients, too) should also keep close tabs on the reimbursement amount and denials they are receiving in the coming year to keep a pulse on the level of coverage for these procedures.
These changes demonstrate the importance of having scientific data for procedures. It is possible that iStent and Hydrus Microstent might return to satisfactory reimbursement levels and overall coverage based on the robust, multicenter studies that allowed them to gain FDA approval initially. Dr. Radcliffe says physicians and scientists have a duty to push for data, participate in clinical research when they can, and help advance science.
A physician’s ability to perform surgeries may depend upon the amount of evidence available for procedures. Therefore, a vast dataset creates a greater opportunity for surgeons to do what they do best—help their patients by performing such procedures to manage their disease.
Conclusion
The changes to reimbursement of MIGS procedures highlight the value and need to strive for the availability to produce robust, thorough data. It is valuable for industry professionals and patients to speak up about the value of MIGS and continue pushing for more science.
Moving forward, patients impacted by these rulings are recommended to keep a close eye on updates regarding MIGS coverage in the coming year to ensure that they continue the conversation with their surgeon and co-managing optometrists on what is deemed appropriate glaucoma management and treatment depending on the level of disease severity.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, and materials available herein are for general information purposes only. Further, the medical opinions and views expressed are those of Nathan Radcliffe, MD,and not those of any manufacturer of microinvasive glaucoma surgery devices or surgical instruments.
